Decision Date2021-04-12
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere is a medical device manufactured by Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2021-04-12 under approval number K210436. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere?
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere is a medical device that received FDA 510(k) clearance on 2021-04-12. It is manufactured by Alcon Laboratories, Inc.. The 510(k) number is K210436.
When was Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere approved by the FDA?
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere received FDA 510(k) clearance on 2021-04-12, under approval number K210436.
What company makes Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere?
Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere is manufactured by Alcon Laboratories, Inc..
What is the FDA product code for Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere?
The FDA product code for Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere is LPL.
Other Devices by Alcon Laboratories, Inc.
K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K161288LenSX Laser System
K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
K162596AIR OPTIX COLORS
K160609AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric
K153642DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
View all 43 devices →
Related Devices (Code: LPL)
K161739Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact LensesPegavision Corporation
K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES ProgressivesAlcon Laboratories, Inc.
K160245Visco (olifilcon A) soft contact lensVisco Vision, Inc.
K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.
K162596AIR OPTIX COLORSAlcon Laboratories, Inc.
K161931Toricolors (hioxifilcon D) Soft Contact LensesPolydev , Ltd.
Official Source
View on FDA Database →
Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.